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FDA OKs icotec’s VADER Pedicle System Navigated Instruments

The navigated instruments aim to advance precision and safety in spinal implantation.

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By: Sam Brusco

Associate Editor

icotec has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its VADER pedicle system navigation instruments, enhancing its portfolio of spine surgery solutions using BlackArmor Carbon/PEEK implants.
 
The company integrated assistive tech like navigation into its instrumentation. The newly cleared Navigation set included a range of instruments for both open and minimally invasive surgery.
 
“Receiving FDA 510(k) clearance for our navigated instrumentation is a significant achievement for icotec,” Roger Stadler, CEO at icotec, told the press. “We are proud to offer our surgeons the tools they need to perform these procedures with the utmost precision and confidence. This clearance opens new opportunities for growth and reaffirms our position as the leader in Carbon/PEEK implants and our commitment to keeping a standard surgical technique.”

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